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Result of tDCS in ASD Children With Comorbidities Like PANDAS, Rare Genetic Diseases or Autoimmune Disorders

Results of the Application of 80 Sessions of tDCS for 12 Months in Children Between 6 and 11 Years Old With Autism Spectrum Disorder With Rare Diseases, Genetic Problems or PANDAS

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06368726
Acronym
tDCS&ASD
Enrollment
180
Registered
2024-04-16
Start date
2024-04-01
Completion date
2026-09-02
Last updated
2026-09-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention, EEG With Periodic Abnormalities, Fluency Disorder, Social Behavior, Visual Perceptual Weakness

Brief summary

Results of the application of 100 sessions of tDCS for 12 months in children between 6 and 11 years old with autism spectrum disorder with rare diseases, genetic problems or PANDAS

Detailed description

tDCS will be applied to 90 children diagnosed with ASD with Mu activity in one of their two temporal lobes and to another 90 children tDCS will not be applied but rather conventional treatments such as the Denver method, etc., in addition to collecting their electroencephalograms in eyes open condition, evoked potentials will be performed. with Mismatch Negativity paradigm to calculate the P300 wave every 25 sessions with a rest of 5-6 weeks between every 25 sessions and the changes in voltage and frequency of the EEG will be analysed using FFT & PSD, as well as the latencies and amplitudes of its P300 wave.

Interventions

DEVICEtDCS or Transcranial Direct Current Stimulation

We use weak currents applied over the child's scalp over 30 minutes twice a week during 100 days

DRUGRisperidone

Risperidone Risperidone according to child's weighs

OTHERSham tDCS

Participants will receive sham transcranial direct current stimulation (tDCS). The device and electrode placement will be identical to the active stimulation groups, but the electrical current will be turned off after a brief initial ramp-up period to mimic the physical sensation of active tDCS without delivering therapeutic stimulation.

Sponsors

Spanish Foundation for Neurometrics Development
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Masking description

Assessments regarding clinical recovery will be conducted by an assessor blind to treatment allocation.

Intervention model description

Two groups of childs: 90 childs receive tDCS treatment and 90 traditional treatments with Risperidone educational training, speech therapy and visual training.

Eligibility

Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

* Age between 7 and 15 years old * Diagnosis: PDD, ASD or PANDAS * Have genetic alterations with geneticist reports like: mutation, random mating between organisms, random fertilization or crossing over (or recombination) between chromatids of homologous chromosomes during meiosis. * Natural birth without caesarean or complications * Normal Pregnancy

Exclusion criteria

* Head Trauma * Brain Injuries like meningitis or encephalitis, including SaRS, Herpes or MERS infections * Epilepsy * Rare Diseases with Auto-Immune Disease * Rare diseases with Endocrinology problems * Fever or Biochemical problems in the First Blood Test (First Visit) * Vaccines Reactions

Design outcomes

Primary

MeasureTime frameDescription
FFT12 monthsChange in Voltage for every frequency band
Power Density Spectrum Changes or PSD12 MonthsAmplitude of the PSD
ERP MMN changes12 monthsChanges in P300 wave amplitude
ERP MMN Changes12 MontsChanges in P300 wave latency

Secondary

MeasureTime frameDescription
Attention12 monthsUsing ATTC scale average Scale
Social Skills12 monthsWe used SSRS Scale Total Teacher Scale
Language12 monthsGhostBusters Res Spoken Language and Listening Average Score from 40 Cards
Visual Contact12 monthsP200 wave amplitude in occipital lobe

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 11, 2026